Striatal and Extra-striatal Mechanisms of Falling in Parkinson's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nicolaas Bohnen, MD, PhD, University of Michigan
ClinicalTrials.gov Identifier:
NCT00736671
First received: August 15, 2008
Last updated: March 2, 2016
Last verified: March 2016
  Purpose
This research study will evaluate functions of memory, thinking, eye movements and walking and how these relate to the measurement of certain chemicals (acetylcholine and dopamine) in the brain using an imaging procedure called positron emission tomography (PET). You may know that the brain chemical dopamine, a "neurotransmitter" substance (a chemical messenger that nerve cells need to communicate with each other), is important for the brain to control movements and that the brain chemical acetylcholine may have functions related to mental concentration and attention. At the present time, the investigators have no clear information how these two chemicals in the brain of patients with Parkinson's disease are related to the risk of falling.

Condition
Parkinson's Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Striatal and Extra-striatal Mechanisms of Falling in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Enrollment: 88
Study Start Date: July 2006
Study Completion Date: August 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observational Parkinson's Disease
Observational study of subjects with Parkinson disease
Observational Normal Control aubjects
Observational study of normal control subjects

Detailed Description:
Although most research in PD has a focus on presynaptic dopaminergic denervation, new lessons may be learned by exploring to what extent alterations in non-motor and non-dopaminergic systems may play a role in the balance impairment in this disorder. This project is designed to evaluate striatal pre-synaptic dopaminergic, cortical, thalamic, and brainstem cholinergic, cognitive, and oculomotor mechanisms underlying the risk of falling and imbalance in PD. The proposed study will exploit advances in our center in the development of dynamic biomathematical modeling of electronic platform data, application of specialized cognitive and oculomotor assessments, and positron emission tomography (PET). This novel multi-system approach holds promise for understanding mechanisms of falling in PD beyond pre-synaptic dopaminergic nigrostriatal denervation.
  Eligibility

Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with Parkinson's disease and normal control persons between the ages of 50-85 years are eligible to participate in this study. Participants should be willing and able to comply with study requirements. Normal control persons should not have a history of brain or mental disorders. Both males and females are eligible.
Criteria

Inclusion Criteria:

  • Subjects considered for inclusion will be female or male subjects either currently enrolled or eligible for care at the VA aged 50-85 years, or community volunteers.
  • The racial, gender and ethnic characteristics of the proposed subjects population reflect the demographics of the patient population of the VA. However, extra efforts will be made to recruit women and minorities (see table 5).
  • Children will be excluded from the study.
  • No exclusion criteria shall be based on race, ethnicity, gender, or asymptomatic HIV status.

Exclusion Criteria:

  • Inability to stand or walk independently (i.e., patients in Hoehn and Yahr stage IV and V).
  • Vertiginous disorder.
  • Orthostatic hypotension or unstable cardiovascular disease at risk of syncope (drop in systolic blood pressure of > 20 mm Hg upon standing).
  • History of stroke with focal cortical lesions.
  • Cerebellar, myelopathic or significant radiculopathy syndrome.
  • Diminished light perception in both eyes (< 20/40 corrected OU).
  • Intracranial surgery.
  • Subjects who have participated in other research protocols such that their cumulative radiation absorbed dose to whole body, gonads, bone marrow or lens of the eye would exceed 5 Rem, or dose to other body organs is more than 15 Rem in preceding 12 months.
  • Pregnancy (beta-HCG test within 48 hours of PET study) or breastfeeding.
  • Contra-indications to MRI.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00736671

Locations
United States, Michigan
University of Michigan Functional Neuroimaging, Cognnitive and Mobility Laboratory
Ann Arbor, Michigan, United States, 48106
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Nicolaas Bohnen VAAAHS
  More Information

Responsible Party: Nicolaas Bohnen, MD, PhD, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT00736671     History of Changes
Other Study ID Numbers: HUM00003450 
Study First Received: August 15, 2008
Last Updated: March 2, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on August 22, 2016